Application of Lean Sigma in Pharmaceutical Industry A practitioners reflection

Ivy Leung GSK Australia

Australian Pharmaceutical Industry

Challenges
Productivity & Competitiveness Shrinking of Manufacturing Sector Geographic Isolation

Opportunities
Innovation & Progressive Thinking Collaboration & Partnership Knowledge Sharing & Management Application of Lean & Six Sigma

Lean Sigma Principles

1. Specify value in the eyes of the customer 2. Identify the value stream & eliminate waste & variation 3. Make value flow at the pull of the customer 4. Involve, align & empower employees 5. Continuously improve knowledge in pursuit of excellence

Application of Lean Sigma

Value = f (Quality, Service, Cost) Customers

-- Big C: patients/ doctors/ pharmacists/ health care providers/ regulators -- Small c: Internal customers

Quality
-- Patient safety -- Fit for purpose

Application of Lean Sigma

Quality by Design
---------Critical to Quality Parameters Factors impacting on variability of process outputs Factor range & interaction Process design robustness & optimisation Parameter design Process performance, capability & control Risk based management Quality at source vs multiple checking Uniformity around a target value vs compliance with specifications

Variation-Taguchis View

A little more loss Some Loss Customer target Loss

LSL

Measurement

USL

Taguchi taught the business world that there is monetary loss any time a Product or service deviates from the target.

Application of Lean Sigma

Process Understanding Capability & Control
-- Robust process design & development
---------Robust technology/ process transfer DMAIC PF/CE/CNX/SOP Design of Experiments Control Charting: Address causes of OOC symptoms before they become OOS Understand sources of variation: Process vs measurement system Measurement System Analysis : prospective vs retrospective Error proofing Process Standard work
Capability

Product Variability

Measurement Variability

Process Control

Process Understanding

Retrospective MSA Process

Obtain / Calculate Sigma for Release Product/Tests Usually obtainable from periodic product review

Is Sigma < 4.0 ?

No

No further action required. Process sufficiently capable at this stage

Yes

Perform Retrospective MSA as per GMS MSA Deployment

Gather at least 20 batches of historical data

Knowledge Management : Understand causes of variation and recommend products/methods where further work (e.g. Standard Work, Prospective MSA, Process Improvement) would be of benefit

Application of Lean Sigma

Waste & Variation
-------SOP vs standard work VA vs NVA activities 7 Wastes Process RFT Testing RFT Documentation RFT Line/ equipment OEE
Time Value Map
Ventolin Nebules Bulk Bx Review / Release Cycle Time = 1.75hr (105')

Process Flow Mapping

1'
64'

4' 12' 1' 8'

15'

Value Added

Non-Value Added

Application of Lean Sigma

Lab Bench Top Before 5S

Lab Bench Top After 5S

Application of Lean Sigma

Microbiology Lab Heijunka System

Flow
-- FIFO vs Laboratory scheduling -- Visual control vs Spreadsheets

Application of Lean Sigma

Flow
-- FIFO vs Laboratory scheduling -- Visual control vs Spreadsheets
Chemistry Lab Heijunka System

Chemistry Lab Sample Label

Application of Lean Sigma

Microbiology Lab Qantas board

Flow
-- FIFO vs Laboratory scheduling -- Visual controls vs Spreadsheets -- Pull vs push

Application of Lean Sigma

Spaghetti Chart Visual Equipment Home Location

Consumables Kanban

Point of Use Consumables

Application of Lean Sigma

Sterility testing cell load chart

Pull of customer
-- Takt time -- Staff # -- Load levelling

Leading & Managing in a Lean Sigma Environment

Creating the right culture Mentoring & coaching People involvement Visual controls Leadership standard work Adherence to accountability process Sensei & Gamba walk Problem solving & rapid process improvement Systems Thinking Change management Communication Managing expectation Courage & resolve Shadow of the Leader

Leading & managing in a Lean Sigma Environment

Load levelling by Takt time
-- VOC analysis linked to batch release requirements -- Load levelling for products & OQ batch reviewers -- Real time tracking of actual batch review & release completed vs target -- OQ batch review & release operation at the pace of manufacture
Product Category
VNS Bulk Flixotide Bulk Flixonase Bulk Zofran Bulk VNS Filling Flixotide Filling Flixonase Filling Zofran Filling VNS Packing Flixotide Packing Flixonase Packing Zofran Packing Total Total Total Target # Actual # Target # Actual # Target # Actual # Target # Actual # Target # Actual # (Target) (Actual) Bx Bx Bx Bx Bx Bx Bx Bx Bx Bx 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Monday

Tuesday

Wednesday

Thursday

Friday

Root Cause for not Meeting Target :

Leading & Managing in a Lean sigma Environment

Man Material Machine

Real Time OQ Customer Service Performance Monitoring System

-- Tracking of actual OQ batch review & release customer service performance against target -- Cause & Effect Analysis -- Action planning & tracking -- Re-load levelling to cover staff leave & unforeseen issues

UDE
Poor process performance

C = Control mechanism (SOP) in place N = Noise no control mechanism in place X = Variables things that can be changed to optimise / control Outcomes UDE Undesirable Effect (the problem) Environment Method Measurement

Agenda Item
Performance Status

Action

Comments

Source of Variation

Root Cause of Variation / Poor Performance

Trends